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"ABSTRAKKesehatan merupakan hak asasi manusia dan salah satu unsur kesejahteraan yang harus diwujudkan sesuai dengan cita-cita bangsa Indonesia sebagaimana dimaksud dalam Pancasila dan Undang-Undang Dasar Negera Republik Indonesia Tahun 1945. Apoteker memiliki peran yang penting dalam industri farmasi agar obat yang dihasilkan bermutu, aman dan berkhasiat. Penerapan CPOB di PT. Taisho Pharmaceutical Tbk. mengikuti aspek-aspek yang tertera dalam CPOB yaitu manajemen mutu, personalia, bangunan dan fasilitas, peralatan, sanitasi dan higiene, produksi, pengawasan mutu, inspeksi diri dan audit mutu, penanganan keluhan terhadap produk, penarikan kembali obat dan produk kembalian, dokumentasi, pembuatan dan analisis berdasarkan kontrak, serta kualifikasi dan validasi

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ABSTRACTHealth is a human right and one of the elements of welfare that must be realized in accordance with the ideals of the Indonesian nation as referred to in Pancasila and the Constitution of the Republic of Indonesia in Year 1945. Pharmacists have an important role in the pharmaceutical industry for the resulting drug quality, safe and efficacious. Implementation of CPOB at PT. Taisho Pharmaceutical Tbk. followed the aspects contained in the CPOB namely quality management, personnel, buildings and facilities, equipment, sanitation and hygiene, production, quality control, self inspection and quality audit, complaints handling products, drug recalls and return products, documentation, and contractual analysis, as well as qualification and validation."

"Praktek kerja profesi apoteker di PT Taisho Pharmaceutical Indonesia Tbk dilakukan agar calon apoteker mendapatkan bekal pengetahuan dan pengalaman yang memadai untuk melakukan pekerjaan kefarmasian serta aplikasi prinsip CPOB di Industri farmasi Tugas khusus yang dikerjakan berjudul Evaluasi Prosedur Tetap Penyiapan dan Penanganan Logbook di PT Taisho Pharmaceutical Indonesia Tbk Evaluasi dilakukan untuk menghilangkan sesuatu yang tidak diperlukan yang bersifat ganda serta melengkapi kelengkapan data yang penting untuk dijadikan focus utama Hasil dari evaluasi yang dilakukan adalah benrtuk standar format logbook dan prosedur tetapnya yang diaplikasikan di senua departemen di PT Taisho Pharmaceutical Indonesia Tbk

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Pharmacists Professional Practice at PT. Taisho Pharmaceutical Indonesia Tbk., aims to make the pharmacist candidate got enough experience and education to do the pharmaceutical jobs and also the application of GMP in pharmaceutical industry. The special assignment was evaluation of standard operational and procedure about preparation and management of logbook at PT. Taisho Pharmaceutical Indonesia Tbk., The evaluation aims to eliminate the unwanted things that doubled and also to complete the data needed that use as the main focus. The result of this evaluation is standardize logbook and the standard operation and procedure that applicable in all department in PT. Taisho Pharmaceutical Indonesia Tbk."

"Pharmaceutical Industry is the place to meet the needs of public health by increasing the quantity and quality of the drug to be in production All drugs are in production and will be circulated to be guaranteed safety efficacy and quality To achieve this we need a guideline that covers all aspects of production and quality control in order to ensure the drug is made consistently meeting the requirements set out and in accordance with their intended use namely the Good Manufacturing Practice GMP All GMP pharmaceutical industry shall apply in all aspects and activities of a series of drug manufacturing Work Practice Pharmacist PKPA conducted during the period 17 June to 30 August 2013 in the PT Taisho Pharmaceutical Indonesia Tbk to provide supplies for prospective pharmacists to apply the knowledge they have learned during the course in a practical and direct the quality control of drugs in the Pharmaceutical Industry The PKPA activities aimed to compare the application of the provisions of the implementation of GMP in Pharmaceutical Industry particularly in PT Taisho Pharmaceutical Indonesia Tbk dan understand the duties and responsibilities of pharmacists in the Pharmaceutical Industry is mainly in charge of production quality assurance and quality control "

"Praktek Kerja Profesi Apoteker di PT. Taisho Pharmaceutical Indonesia Tbk. bertujuan untuk membuat mahasiswa mengetahui serta memaghami aspek-aspek yang berhubungan dengan penerapan CPOB di Industri farmasi. Selain itu juga untuk mengetahui dan memahami peran dan tanggung jawab apoteker di Industri farmasi khususnya pada posisi kunci yakni produksi, pengawasan mutu dan penjaminan mutu. Tugas khusus yang diberikan adalah melakukan penyerderhanaan terhadap metode pengujian produk akhir (Departemen Quality Operation) yang bertujuan supaya mahasiswa mengerti dan memahami cara untuk mempersiapkan dan membuat metode pengujian yang lebih sederhana dan juga mengetahui bagaimana menyiapkan catatan hasil pemeriksaan.

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Apothecary Internship Program at PT. Taisho Pharmaceutical Indonesia Tbk. aims to make college student aware about aspects related to the implementation of GMP in the pharmaceutical industry and also to know and understand the roles and responsibilities of pharmacists in the pharmaceutical industry, especially for the Key personel, i.e. production, quality control and quality assurance. Specific assignment given was simplification of analycal method finished good (Quality Operation Department) aims to make college student understand how to prepare and design analysis method finished good as well as how to prepare of laboratory report."

"ABSTRAKPraktek kerja profesi apoteker di PT. Taisho Pharmaceutical bertujuan untuk mengetahui peran serta tanggung jawab apoteker dalam industri farmasi. Peranan penting apoteker di industri farmasi antara lain dalam proses produksi, pengendalian mutu dan pemastian mutu dari produk farmasi yang dihasilkan. Pada proses produksi, salah satu peran apoteker adalah menjamin proses produksi dijalankan sesuai dengan Cara Pembuatan Obat yang Baik. PT. Taisho Pharmaceutical melakukan simplifikasi pada proses set up dan cleaning total yang mengacu pada lean manufacturing. Selama program praktik kerja ini, telah berhasil dilakukan simplifikasi proses set up dan cleaning total pada mesin filling IWKA dari beberapa produk seperti myco-z cream, daktarin cream 5 gram.

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ABSTRACTPharmacist internship in PT. Taisho Pharmaceutical aims to know the role and responsibility of pharmacists in the pharmaceutical industry. The important role of pharmacists in the pharmaceutical industry, among others, in the production process, quality control and quality assurance of pharmaceutical products produced. In the production process, one of the pharmacists 39 role is to ensure the production process is executed in accordance with Good Manufacturing Practice. PT. Taisho Pharmaceutical simplifies the total set up and cleaning process that refers to lean manufacturing. During this practical work program, there has been a complete simplification of set up and cleaning process on IWKA filling machine from some products such as myco z cream, daktarin cream 5 gram."

"ABSTRAKPraktek kerja profesi Apoteker di PT. Taisho Pharmaceutical Indonesia, Tbk. bertujuan untuk mengetahui peran, tugas dan tanggung jawab Apoteker di Industri Farmasi, memiliki wawasan, pengetahuan, ketrampilan dan pengalaman praktis untuk melakukan pekerjaan kefarmasian di Industri Farmasi; memahami penerapan CPOB di Industri Farmasi dan memiliki gambaran nyata tentang permasalahan pekerjaan kefarmasian di Indsutri Farmasi. Selama PKPA,mahasiswa dibekali dengan training CPOB, sertifikat halal, dan EHS Environment, Health, and Safety , serta ditempatkan di Pengawasan Mutu. Kegiatan di Pengawasan Mutu adalah melakukan verifikasi metode pengujian yang dilakukan oleh analis terhadap dokumen spesifikasi dan metode pengujian produk jadi yang bersumber dari Farmakope Indonesia dan United State Pharmacopeia USP . Kegiatan lainnya adalah melakukan analisis terhadap biaya yang dikeluarkan untuk pengujian produk jadi. Berdasarkan PKPA yang telah dilakukan, dapat disimpulkan bahwa Apoteker di PT. Taisho Pharmaceutical Indonesia, Tbk. mempunyai peranan, tugas, dan tanggung jawab poada bagian produksi, pengawasan mutu, dan pemastian mutu.

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ABSTRACTInternship in PT Taisho Pharmaceutical Indonesia, Tbk. aims to understand the role, duties, and responsibilities of apothecary in the pharmaceutical industry, have the insight, knowledge, skills, and practical experience to do the work of Apothecary in the pharmaceutical industry, understanding the application of GMP in the pharmaceutical industry, and have a real picture of the problems of pharmaceutical jobs in the pharmaceutical industry. During internship, students are equipped with the training of GMP, Halal certificate, and EHS Environment, Health, and Safety , and placed in the Quality Control. Activities in quality control is to verify the testing method undertaken by the analyst against the spesification document and test method of the finished good product originating from Pharmacopeia Indonesia and United State Pharmacopeia USP . Another activity is to analyze the costs incurred for testing the finished product. Based on internship that the pharmacist at PT. Taisho Pharmaceutical Indonesia, Tbk. has a role, duties, and responsibilities in production, quality control, and quality assurance."

"ABSTRAKPraktek Kerja Profesi Apoteker di PT. Taisho Pharmaceutical Indonesia, Tbk. memiliki tujuan agar calon Apoteker mampu mengerti peranan, tugas dan tanggung jawab apoteker di Industri Farmasi; memiliki wawasan, pengetahuan, keterampilan, dan pengalaman praktis untuk melakukan pekerjaan kefarmasian di Industri Farmasi; memahami penerapan Cara Pembuatan Obat yang Baik CPOB di Industri Farmasi; dan memiliki gambaran nyata tentang permasalahan pekerjaan kefearmasian di Industri Farmasi. Tugas khusus yang diberikan berjudul Risk Assessment Prosedur Pembuatan, Pengendalian Bill of Material pada Sistem BPCS dan Pembuatan Shop Order Copy Prosedur Pengolahan dan Pengemasan Induk. Tujuan dari tugas khusus ini adalah agar mampu membuat risk assessment proses pembuatan dan pengendalian Bill of Material BOM pada sistem BPCS dan risk assessment pembuatan Shop Order Copy prosedur pengolahan dan pengemasan induk.

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ABSTRACTInternship at PT. Taisho Pharmaceutical Indonesia, Tbk. aims for pharmacist candidate to be able to understand the roles, duties and responsibilities of pharmacists in pharmaceutical industry has the concepts, knowledges, skills, and practical experiences to perform pharmaceutical services in pharmaceutical industry understand the application of Good Manufacturing Practice GMP in pharmaceutical industry and has the clear vision about pharmaceutical service issues in pharmaceutical industry. Given a special assignment titled Risk Assessment of the Making, Controlling Bill of Material on BPCS System Procedure and the Making of Shop Order Copy Manufacturing and Packaging Instruction. The purpose of this special assignment is to make risk assessment of the Bill of Material BOM creation and management process on the BPCS system, and risk assessment of Shop Order Copy Manufacturing and Packaging Instruction creation."

"ABSTRAKPraktek Kerja Profesi Apoteker dilaksanakan di PT. Taisho PharmaceuticalIndonesia Tbk. Jalan Raya bogor KM 38. Kegiatan PKPA ini bertujuan agarmahasiswa profesi apoteker dapat melihat langsung aktivitas yang berlangsungdalam suatu industri farmasi, memperoleh pengetahuan dan wawasan tentangsegala aspek yang terkait di industri farmasi terutama dalam hal penerapan CPOBdi PT. Taisho Pharmaceutical Indonesia dan dapat memiliki pemahaman yangmendalam mengenai peran dan tugas apoteker di industri farmasi. Tugas khususyang diberikan berjudul Pembuatan Format Annual Product Quality Review(APQR)

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ABSTRACTPharmacists Professional Practice implemented in PT. Taiho PharmaceuticalIndonesia Tbk., Jalan Raya Bogor KM38. PKPA activity is intended that studentscan see the direct profession pharmacists activity that takes place in thepharmaceutical industry, gaining knowledge and insight into everything relatedaspects in the pharmaceutical industry, especially in terms of the implementationof GMP in PT. Taisho Pharmaceutical Indonesia Tbk. and may have a deepunderstanding of the role and duties of the pharmacist in the pharmaceuticalindustry. Special task given New Format of Annucal Product Quality Review (APQR)."

"Praktek Kerja Profesi Apoteker dilaksanakan di PT. Taisho Pharmaceutical Indonesia – Jalan Raya Bogor Km 38 Bogor. Kegiatan PKPA ini bertujuan untuk meningkatkan pengetahuan dan wawasan tentang segala aspek yang terkait di industri farmasi terutama dalam hal penerapan CPOB di PT. Taisho Pharmaceutical Indonesia Tbk. dan dapat memiliki pemahaman mengenai tanggung jawab apoteker di industri farmasi. Tugas khusus yang diberikan berjudul Kajian Pengambilan Sampel IPC Produk Sirup Penurun Panas untuk Anak dalam Interval Waktu Satu Jam. Tugas khusus ini bertujuan untuk mengkaji kemungkinan menurunkan separuh dari frekuensi pengambilan sampel dalam pengawasan selama proses pengisian produk cairan penurun panas untuk anak dengan pengujian secara statistik.

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Pharmacist Internship Program at PT. Taisho Pharmaceutical Indonesia – Jalan Raya Bogor Km 38 Bogor was intended to acquire knowledge and insight about every aspect in pharmaceutical industry which particularly focus on GMP implementation in PT. Taisho Pharmaceutical Indonesia Tbk as well as the responsibilities of Pharmacist in pharmaceutical industry. The special task given was Sampling Studies of IPC Fever Reducer Syrup Product for Children in One Hour Interval. This assignment was aimed to study about the possibility of reducing half of the control sampling frequency during the liquid products filling process for fever reducer by using statistical method."

"Industri Farmasi adalah badan usaha yang memiliki izin dari Menteri Kesehatan untuk melakukan kegiatan pembuatan obat dan bahan obat. Pemerintah Indonesia melalui Keputusan Menteri Kesehatan No.43/Menkes/SK/II/1988 tentang Cara Pembuatan Obat yang Baik (CPOB) berusaha menjamin mutu obat yang dihasilkan industri farmasi meliputi serangkaian kegiatan produksi hingga obat jadi yang dihasilkan memenuhi syarat dan sesuai dengan tujuan penggunaannya. Penerapan pedoman CPOB ini diharapkan dapat meningkatkan mutu produk obat secara terus menerus dan memberikan perlindungan terhadap kesehatan masyarakat serta menjadi langkah progresif bagi perkembangan industri farmasi di Indonesia sehingga mendapat pengakuan dan kepercayaan dari konsumen. Oleh karena itu, apoteker harus memiliki kompetensi yang baik dalam menjamin pelaksanaan CPOB berjalan sesuai persyaratan. Praktek Kerja Profesi Apoteker (PKPA) yang dilakukan pada 9 September - 31 Oktober 2013 di PT. Taisho Pharmaceutical Indonesia Tbk. dalam rangka memperoleh pengetahuan dan wawasan mengenai penerapan aspek-aspek CPOB di PT. Taisho Pharmaceutical Indonesia Tbk. serta memahami peran dan tugas apoteker dalam industri farmasi.

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Pharmaceutical Industry is an entity that has the permission of the Minister of Health to conduct the manufacture of drugs and drug ingredients. Indonesian Government through the Minister of Health No.43/Menkes/SK/II/1988 on Good Manufacturing Practice (GMP) seeks to ensure the quality of drug produced by the pharmaceutical industry includes the production of a series of events to be generated drug and qualified in accordance with the intended use. The application of GMP guidelines is expected to improve the quality of drug products continuously and provide protection to public health as well as being a progressive step for the development of the pharmaceutical industry in Indonesia, so it gets the recognition and trust of consumers. Therefore, pharmacists must have a good competence in ensuring the implementation goes according to GMP requirements. Pharmacist Internship Program (PKPA) conducted on September 9th to October 31th 2013 in the PT. Taisho Pharmaceutical Indonesia Tbk. in order to gain knowledge and insight about the implementation aspects of GMP in PT. Taisho Pharmaceutical Indonesia Tbk. and understand the role and duties of the pharmacist in the pharmaceutical industry."